Insulin Glargine v Rosiglitazone as add-on Therapy in Patients Failing Sulfonylurea and Metformin Combination Therapy

January 10, 2011 updated by: Sanofi
To compare the glycemic control, as measured by HbA1C, between insulin glargine and rosiglitazone add-on therapies in patients who fail oral combination of a sulfonylurea and metformin

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

220

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • Sanofi-Aventis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

INCLUSION CRITERIA:

  • Diagnosis of type 2 diabetes mellitus for at least one year;
  • Continuous treatment with at least half maximally labeled dose of a sulfonylurea and at least 1000 mg metformin daily for at least three months ;
  • Glycated hemoglobin between 7.5 and 11 % units, inclusive;
  • Willingness to accept, and ability to inject insulin glargine therapy

EXCLUSION CRITERIA:

  • Stroke, MI, coronary artery bypass graft, percutaneous transluminal coronary angioplasty or angina pectoris within the last 12 months;
  • Congestive heart failure requiring pharmacological treatment;
  • Serum creatinine > 1.5 mg/dl for males, or > 1.4 mg/dl for females;
  • Acute or chronic metabolic acidosis, including diabetic ketoacidosis;
  • Planned radiological examinations requiring administration of contrasting agents;
  • Clinical evidence of active liver disease, or serum ALT 2.5 times the upper limit of the normal range;
  • History of hypoglycemia unawareness;
  • Pregnancy or lactation;
  • Failure to use adequate contraception (women of current reproductive potential only);
  • Known hypersensitivity to insulin glargine, rosiglitazone or any of the components of insulin glargine rosiglitazone;
  • BMI >25 kg/m2;
  • Malignancy except basal cell carcinoma within the last five years;
  • History of substance or alcohol abuse within last two years, or current addiction to substance or alcohol abuse;
  • Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with completion of the study;
  • Incapability to comply with study procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary efficacy variable was the change in HbA1C from baseline to the end of therapy.
Other efficacy variables were the change from baseline in FPG, serum lipids and weight.

Secondary Outcome Measures

Outcome Measure
Secondary efficacy parameters were: a mean change from baseline in FPG
Mean change from baseline in fasting insulin/C-peptide levels
Mean change from baseline in lipid levels (total cholesterol, HDL, LDL, TG, free fatty acids)
Mean change from baseline for bodyweight.
Health-related quality of life was compared between the baseline visit and the follow-up assessments

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Karen Barch, Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Study Completion

June 1, 2002

Study Registration Dates

First Submitted

July 28, 2006

First Submitted That Met QC Criteria

July 28, 2006

First Posted (Estimate)

July 31, 2006

Study Record Updates

Last Update Posted (Estimate)

January 11, 2011

Last Update Submitted That Met QC Criteria

January 10, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOE901_4014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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